JUST IN: Moderna asks U.S. regulators to authorize low doses of its COVID-19 vaccine for children younger than 6, a long-awaited move toward potentially opening shots for millions of tots by summer.
While questions are swirling about what's taking so long, Marks pointedly told lawmakers this week that the FDA can't evaluate a product until a manufacturer completes its application. FDA will publicly debate the evidence with its scientific advisers before making a decision, and Marks said multiple meetings would be set to cover several expected applications.
If FDA clears vaccinations for the littlest, next the Centers for Disease Control and Prevention would have to recommend who needs them -- all tots or just those at higher risk from COVID-19.“We’ve been kind of left behind as everybody else moves on,” said Meagan Dunphy-Daly, a Duke University marine biologist whose 6-year-old daughter is vaccinated -- but whose 3-year-old and 18-month-old sons are part of Pfizer’s trial.
Some parents even have urged the government to let families choose shots before all the evidence is in. But the vaccine proved between about 40% and 50% effective at preventing symptomatic COVID-19 during the trial. Burton blamed the omicron variant's ability to partially evade vaccine immunity, noting that unboosted adults showed similarly less effectiveness against milder omicron infections. While no children became severely ill during the study, he said high antibody levels are a proxy for protection against more serious illness — and the company will test a child booster dose.
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